Meaning
Detailed compilations of technical documents demonstrating that a plastic product complies with all relevant regulatory and safety standards are required for market entry. This assembly of records, which forms the declaration of conformity technical dossier, must be maintained by the manufacturer for at least ten years after the product is placed on the market. It includes detailed descriptions of the raw materials, the manufacturing processes, and the results of all migration tests.
The document must be made available to market surveillance authorities upon request to verify compliance with regional directives.
Essential Component
Material safety data sheets, formulation disclosures, and migration test reports constitute the core of the compiled regulatory records. For food-contact polymers, the dossier must include specific documentation showing that the polymer additives do not exceed their specific migration limits. It also requires detailed drawings of the finished part and a description of the manufacturing process, such as injection moulding or extrusion.
These components ensure that every aspect of the supply chain is fully documented and traceable.
Verification Process
Third-party laboratory analysis and internal quality control audits provide the empirical data needed to validate the assertions made in the documentation. Independent laboratories perform overall and specific migration testing on representative samples of the molded plastic parts. The results must show compliance with the limits set by relevant authorities, such as the European Food Safety Authority.
This verification step ensures that the chemical composition of the plastic remains stable under simulated use conditions.
Risk Assessment
Hazard evaluations and exposure scenarios must be detailed within the documents to address any potential chemical migration during normal product usage. The analysis considers the surface-to-volume ratio of the polymer part and the temperature of the foodstuff during contact. This risk assessment determines whether any trace degradation products or unreacted monomers present a hazard to consumer health.
Complete documentation protects the manufacturing organization against liability and product recalls.
